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FDA 510(k) Application Details - K202884
Device Classification Name
Powered Laser Surgical Instrument With Microbeam\Fractional Output
More FDA Info for this Device
510(K) Number
K202884
Device Name
Powered Laser Surgical Instrument With Microbeam\Fractional Output
Applicant
AVAVA, Inc.
275 Second Avenue, Floor 3
Waltham, MA 02451 US
Other 510(k) Applications for this Company
Contact
Lewis Levine
Other 510(k) Applications for this Contact
Regulation Number
878.4810
More FDA Info for this Regulation Number
Classification Product Code
ONG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/28/2020
Decision Date
04/13/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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